Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI/DI 4026704547678, Batch Numbers: 18FG05, 18GG12, 18GG17, 18GG31, 18GT32, 18HG12, 18HG16, 18IG02, 18IG06, 18IG15, 18IG21, 18IG27, 18JG02, 18JG23, 18JG32, 18JG34, 18KG15, 18KG23, 18LG02, 18LG22, 18LG28, 19AG21, 19AG24, 19AG27, 19AG37, 19BG25, 19BG40, 19CT65, 19ET72, 19FT01, 19GT05, 19GT20, 19GT59, 19GT65, 19HT40, 19HT61, 19HT80, 19IT29, 19IT39, 19JT18, 19JT22, 19JT29, 19JT49, 19JT57, 19KT08, 19LT04, 19LT48, 20AT09, 20AT32, 20AT44, 20AT46, 20AT53, 20BT23, 20BT37, 20BT47, 20CT05, 20CT12, 20CT36, 20DT37, 20ET16, 20ET28, KME20J0318, KME20K0152, KME20K0153, KME20K0154, KME20K3587, KME20L1467, KME20L1468, KME20L1838, KME20M2048, KME20M2480, KME21A0669, KME21A1897, KME21A2807, KME21B1674, KME21B1675, KME21C0489, KME21M0865, KME21M2740, KME21M2741, KME22B2144, KME22B2326, KME22B2327, KME22C1075, KME22C1826, KME22C3192, KME22D0787, KME22E0223, KME22E1029, KME22F0563, KME22G0910, KME22G0911, KME22H0780, KME22H2909, KME22J0577, KME22K0015, KME22K0016, KME22K0202, KME22K0335, KME22K0918
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
TELEFLEX LLC
Reason for Recall:
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506530

Product Codes/Lot Numbers:

UDI/DI 4026704547678, Batch Numbers: 18FG05, 18GG12, 18GG17, 18GG31, 18GT32, 18HG12, 18HG16, 18IG02, 18IG06, 18IG15, 18IG21, 18IG27, 18JG02, 18JG23, 18JG32, 18JG34, 18KG15, 18KG23, 18LG02, 18LG22, 18LG28, 19AG21, 19AG24, 19AG27, 19AG37, 19BG25, 19BG40, 19CT65, 19ET72, 19FT01, 19GT05, 19GT20, 19GT59, 19GT65, 19HT40, 19HT61, 19HT80, 19IT29, 19IT39, 19JT18, 19JT22, 19JT29, 19JT49, 19JT57, 19KT08, 19LT04, 19LT48, 20AT09, 20AT32, 20AT44, 20AT46, 20AT53, 20BT23, 20BT37, 20BT47, 20CT05, 20CT12, 20CT36, 20DT37, 20ET16, 20ET28, KME20J0318, KME20K0152, KME20K0153, KME20K0154, KME20K3587, KME20L1467, KME20L1468, KME20L1838, KME20M2048, KME20M2480, KME21A0669, KME21A1897, KME21A2807, KME21B1674, KME21B1675, KME21C0489, KME21M0865, KME21M2740, KME21M2741, KME22B2144, KME22B2326, KME22B2327, KME22C1075, KME22C1826, KME22C3192, KME22D0787, KME22E0223, KME22E1029, KME22F0563, KME22G0910, KME22G0911, KME22H0780, KME22H2909, KME22J0577, KME22K0015, KME22K0016, KME22K0202, KME22K0335, KME22K0918

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1855-2023

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